RA Internship

Business Unit: Regulatory Affairs

Location: US – Princeton or Remote

• 2025 Summer Internship / Will be remote other than 1st week will be in Princeton, NJ at US HQ (work during Eastern Time Zone hours)
• Runs from June 2nd to August 22nd
• Please note that you MUST be enrolled (during time of internship) in a US accredited Masters of Regulatory Affairs program

Indegene is a healthcare solutions company that enables global healthcare organizations address complex challenges to improve health and business outcomes. The company is passionate about healthcare and finding practical solutions for our customers to get lifesaving drugs to the market faster; make operations run faster; use cognitive technologies to improve decision making; and improve digital content and technology maturity. We look to leverage technology and innovation to disrupt healthcare for the better. To innovate we constantly look ahead and build expertise in emerging capabilities that will drive our customer’s success tomorrow. The Indegene team collaborates seamlessly across teams in 50 countries bringing together diverse capabilities and points of view that seamlessly integrate analytics, technology, operations, and medical expertise

JOB DESCRIPTION

Internship Overview:

Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration, and high performance. As the industry leader in life sciences services, Indegene is where you’ll find unrivaled opportunities to succeed and realize your full potential.

The internship program is a full-time (35-40 hours a week) role that blends real-world experience and provides a broad understanding of the various roles and responsibilities within Regulatory Affairs.

The role will provide training activities that support company goals as well as developmental opportunities through broad-based hands-on experiences on live projects and mentorships which will integrate the interns into various medical and operational initiatives.

• The intern will learn the basics of Regulatory Affairs and Regulatory Operations activities through hands-on experience.
• Contribute to ongoing internal communication channels by maintaining and updating materials, etc.
• Attend key meetings to better understand team responsibilities, publications, content development and workflows.
• Assist the Regulatory Affairs Operations team in their day-to-day functions.

Learning Goals:

• Understand the interaction between Regulatory Affairs and other internal groups in a pharmaceutical industry setting.
• Gain insight of Regulatory Affairs initiatives in the industry / community.

• Enhance written communication skills through preparation of relevant documents for clients.
• Gain experience working in complex, matrixed global team environments by engaging with different departments (e.g. Labelling, Artwork, Medical Writing, Pharmacovigilance, pricing, reimbursement, HEOR and Medical Affairs).
• Upon completion, the interns will understand and be prepared for the challenges of a career in Regulatory Affairs.

Responsibilities:

• Train as a core member of the Regulatory Affairs team to assist in providing accurate, fair- balanced, evidence-based information to internal and external customers.
• Contribute to multidisciplinary teams and build relationships across departments and functions
• Perform industry and market research on regulatory intelligence, policies
• Engage in preparation of client engagement conversations and support new client conversations
• Participate in cross-functional teams to assist with the execution of the strategic plans for clients.
• Provide support to various roles within Regulatory Affairs and other functional groups.
• Support the team through various activities, training, and initiatives that are strategically aligned with client priorities.
• Search literature and critically evaluate published and unpublished data.
• In consultation with the internship supervisor, develop and present one structured presentation relevant to internship activities.

Qualifications:

• Must be authorized to work in the US.
• Must be available full time (40 hours/week)
• Minimum GPA 3.0/4.0
• Applicants must be enrolled in a U.S. accredited university in a regulatory affairs or similar program and in good standing for the semester before the internship.
• Exposure to health authority regulatory requirements, basic principles in clinical trials, exposure to submissions management and dossier compilation and related regulatory operations activities. .
• Understand the different requirements in regulatory submissions management and ability to perform relevant research and collaboration toward market relevant submissions
• Knowledge of different types of submissions by health authority as well as variations in therapeutic area requirements
• Ability to demonstrate strong analytical and quantitative skills is required.
• Ability to balance multiple projects and initiatives while executing results.
• Must be a self-starter works independently while contributing to the team goals
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.
• Proven leadership/participation with campus programs and/or community service activities is desired.

Skills: